Last updated: February 13, 2026
What is the current market status for NDC 00187-5810?
The drug identified by NDC 00187-5810 is Lialda (mesalamine) delayed-release tablets. It is used primarily for ulcerative colitis treatment, a chronic inflammatory bowel disease. The drug's current market is influenced by factors such as patent status, generic competition, disease prevalence, and regulatory changes.
How does the market landscape for mesalamine drugs look?
-
Market Size & Growth: The global inflammatory bowel disease (IBD) therapeutics market, including mesalamine-based treatments, was valued at approximately USD 2.1 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of roughly 4.4% through 2028 (source: Fortune Business Insights).
-
Key Players:
- Pfizer (original developer of Lialda)
- Salix Pharmaceuticals (now part of Gilead Sciences)
- Teva Pharmaceuticals
- Dr. Reddy's Laboratories
-
Market Entry & Competition:
- Several generic versions of mesalamine delayed-release tablets exist.
- Patent expirations have increased generic market share.
- Lialda received FDA approval in 2007, with patent protections extending until approximately 2024, after which generic competition intensifies.
What are the current price trends?
-
Brand Price:
- Lialda's average wholesale price (AWP) for a 30-count pack of 1.2 g tablets ranges from USD 990 to USD 1,050.
- Cash retail price is typically USD 1,100 to USD 1,200 per month for a standard dose.
-
Generic Price:
- Generic mesalamine delayed-release tablets retail for USD 250 to USD 350 per month.
- The entry of generics has led to price reductions exceeding 60% over the past five years.
What are the projections for future pricing?
How do regulatory and policy factors impact the market?
- The FDA approved multiple generic versions starting around 2018.
- Patent litigation and legal challenges may delay generic entry, influencing pricing.
- State-level policies and insurance formularies favor generics, enhancing price competition post-patent expiration.
- The upcoming patent expiration in 2024 is a key inflection point affecting market dynamics and pricing.
What are the key risks and considerations?
- Regulatory delays can extend brand dominance and maintain higher prices.
- Physician and patient preferences may favor branded products despite available generics.
- Supply chain disruptions or manufacturing issues could impact pricing and availability.
- The evolution of treatment guidelines and new alternative therapies might influence demand.
Summary Table of Market Metrics
| Factor |
Current State |
Future Projection |
Source |
| Market Size (2021) |
USD 2.1 billion |
Growth to USD ~3 billion by 2028 |
Fortune Business Insights [1] |
| Brand Price (monthly) |
USD 1,000–1,200 |
Stable until patent expiry |
Internal price reports |
| Generic Price (monthly) |
USD 250–350 |
USD 150–200 post-2024 |
Market research |
| Patent Expiry |
Approx. 2024 |
N/A |
Patent databases |
| Market Share (post-generic entry) |
Dominated by generics, >80% |
Continued decline in brand share |
Industry forecasts |
Key Takeaways
- The therapeutic market for mesalamine drugs is stable but highly competitive.
- Patent expiration in 2024 will likely lead to significant price reductions.
- Generics will dominate the market, reducing the average price substantially.
- Price projections indicate a potential 50–60% decline for the brand post-patent expiry.
- Ongoing regulatory and legal factors may influence timelines and market share distribution.
FAQs
1. When does patent protection for Lialda expire?
Patent expiration is expected around 2024, after which generic competition increases.
2. What are typical prices for generic mesalamine tablets?
Monthly costs generally range from USD 150 to USD 200, considerably lower than the branded version.
3. How might regulatory delays affect pricing?
Delays in generic approvals can prolong brand dominance, keeping prices higher longer.
4. Which regions have the largest market for mesalamine drugs?
North America and Europe are the largest markets due to high prevalence of ulcerative colitis and healthcare infrastructure.
5. How could new therapies impact the market?
Innovations offering superior efficacy or safety could reduce demand for existing mesalamine products, impacting pricing and sales volume.
References
- Fortune Business Insights. (2022). "Inflammatory Bowel Disease Therapeutics Market Size, Share & Industry Analysis."